Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care
Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
Increasing emergence of multidrug resistant (MDR) bacteria worldwide is now considered one of
the most urgent threats to global health. The association between increase of antibiotics
consumption and resistance emergence has been well documented for all patients admitted to
the Intensive care unit (ICU) who received antibiotic treatment and for patients treated for
ventilator associated pneumonia (VAP).
Reduction of use of antibiotics is a major point in the war against antimicrobial resistance.
VAP is the first cause of healthcare-associated infections in ICU and more than half of
antibiotics prescriptions in ICU are due to VAP.
Once the diagnosis of pneumonia under MV has been made, initiation of antibiotic treatment
must be prompt but there is no clear consensus on its duration. In the case of a good
clinical response to treatment, it has been shown in some situations that short course
antibiotics can be effective without side effects and antimicrobial stewardship initiatives
can be applied successfully and effectively to the management of Community Acquired Pneumonia
(CAP).
The hypothesis is that an antimicrobial stewardship is possible in the treatment of VAP with
no increase in the rate of all-cause mortality, treatment failure or occurrence of new
episode of pneumonia.
The objective is to investigate whether an antimicrobial stewardship for VAP based on daily
assessment of clinical cure and antimicrobial discontinuation, if it is obtained, would be
non-inferior in terms of all-cause mortality, treatment failure or occurrence of new episode
of pneumonia.
This study will be a prospective, national multicenter (24 centers), phase III, comparative
randomized (1:1), single-blinded clinical trial comparing two management strategies of
treatment of pneumonia on the basis of two parallel arms:
Experimental group: Antimicrobial stewardship based on daily clinical assessment of clinical
cure.
Control group: standard management: duration of appropriate antibiotic therapy for confirmed
VAP according to guidelines.